# K972361: V40 Zirconia Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Sep 23, 1997 after 90 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920577 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952418: V40 Zirconia Femoral Heads, Howmedica Corp. (1995) Summary page 1.
- K920577: Howedica Zirconia Femoral Head, Howmedica Corp. (1992) Summary page 1.

## Most influential descendants
- K993889: Exeter Ceramic Femoral Heads (2000), 0 descendants of its own

## Indications for use
The V40 Zirconia Femoral Heads are intended to be used with modular femoral components in primary and secondary cemented or cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis.

Source page: https://510kreport.com/device/K972361
Methodology: https://510kreport.com/methodology